Many people suffering from severe hip or pelvic bone problems resort to a major surgical operation called hip replacement surgery. In this type of surgical procedure, the hip joint is replaced by any of the currently available artificial prosthetics, either as a total hip replacement operation (in which both the femoral head and the acetabulum are replaced) or merely a hemi replacement (involving only one femoral head).
Arthroplasty of this kind is the most common surgical operation performed today, with more than 200,000 individuals receiving this treatment every year in the US alone. Unfortunately, it is also currently one of the most controversial fields of orthopedics.
In the past few years, a number of hip implants from supposedly prestigious and quality-centric manufacturers have been recalled and taken off the market. The recalls are due to the rising number of complaints and lawsuits from suffering or angry patients, who point out several defects in the faulty hip implants.
The following are the hip implant manufacturers that have recalled their arthroplasty-related products.
DePuy Orthopaedics, Inc.: A unit of Johnson & Johnson, DePuy was on the leading edge of advanced artificial hip implants. The company was among the first ones that sought improvements on the then standard metal-on-plastic hip replacements. When it introduced its all-metal (both the ball and joint are made of a supposedly tough but biologically inert metallic alloy) artificial hip implants almost a decade ago, its brochures and company representatives touted the products as the “Cadillac” of hip implants. Buying into the claim, with the term “all-metal” seemingly as durable as it sounded, many orthopedic surgeons and their patients opted for DePuy’s ASR XL Acetabular System and the ASR Hip Resurfacing System hip implants.
However, as early as 2007, responding to complaints from patients and doctors regarding the defects with DePuy’s artificial hip implants, the National Joint Replacement Registry in Australia sternly warned the company about the need for a product recall. However, DePuy refused to take the products off the market, insisting on the supposed excellence of the said hip implants. That is why since 2007, despite the early warnings, tens of thousands of DePuy’s supposedly failure-prone hip replacements were implanted in patients, believing in the company’s claims regarding the said metal-on-metal hip implants’ “better durability” than older models.
The breaking point, however, occurred in August 2010 as DePuy finally performed a recall of its hip implant products due to the undeniable deluge of lawsuits and claims. The problem with DePuy’s metal-on-metal hip implants, as it turned out, was its high failure rate that reaches about 13%. For the orthopedic industry, such a failure rate is unacceptable, as this simply means more than one in 10 patients receiving the implant would have to undergo a “revision” surgery not in 15 years, but in less than five, sometimes even within a couple of years. This outcome is particularly revolting for implant recipients who most often had chosen to have DePuy’s hip replacements after having been assured of the implants’ “exceptional durability.”
Zimmer Holdings, Inc.: Zimmer is the maker of the Zimmer Durom Cup hip replacement system. The said cup is surgically placed in the hip socket. When reports of the product’s failure first surfaced, Zimmer denied the allegation and insisted that the fault was due to the error surgeons committed during implantation. In July 2008, however, Zimmer finally recalled its product as more reports surfaced pointing out the Durom Cup’s high failure rate. Among the chief complaints of hip implant recipients include the tendency of the cup to loosen even during surgery, and its tendency to fail in a few years, necessitating another costly and very painful revision surgery.
Stryker: In the company’s effort to find hip replacement systems that are supposedly “better” than metal-on-plastic artificial hips, Stryker came out with ceramic-based hip implants in 2003 under its Trident line. On paper, ceramic is supposed to be highly resistant to wear and tear, and thus, should be more durable than metal-on-plastic hip replacement systems. As it turned out, however, the use of ceramics introduced hitherto unexpected side-effects.
Stryker’s Trident Acetabular PSL and the Trident Hemispherical Cups were found to have a number of design or manufacturing defects that might cause injuries, if they have not already. These devices also tend to produce “squeaky and popping” noises, arising from ceramic grinding against ceramic. In fact, the noise is often so audible that it is enough to cause implant recipients significant social embarrassment: the mere act of walking or changing one’s seating position is enough to produce the “squeaky” sound.
More importantly, doctors are apprehensive that the noise is just prelude or indicative of damage that occurs within, aside from the concern that the ceramics may produce debris that could contaminate the patient’s bloodstream. Pressured by the FDA, the company eventually recalled the said two devices, and is now responding to lawsuits filed against it.
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